Protein C DeficiencyNCT04180657
Ghrelin Levels in Patients With Protein C Deficiency
An observational study of Protein C Deficiency, run by University of Aarhus.
Trial summary
In rodents with protein C deficiency elevated levels of ghrelin has been observed. The purpose of this study is to investigate if patients with protein C deficiency also have elevated levels of ghrelin, and if so, how this affects the patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein C Deficiency
- What is being tested?
- Protein C deficiency
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with protein C deficiency and gender and BMI matched controls.
Who may be able to join
- protein C deficiency or healthy subjects
- age 18-70
- BMI 18-35
- written statement to join the study
Who cannot join
- chronic illness, apart from protein C deficiency and lifestyle diseases
- everyday medication apart from statins, oral diabetes medication and antihypertensive drugs.
- blood donation within three months prior to the investigation.
- Alcohol abuse
Trial locations and contacts
No sites are listed yet.
Rakel F Johansen, MD contact
About this study
Official title: Investigation of Ghrelin Levels in Patients With Protein C Deficiency
In rodents with protein C deficiency elevated levels of ghrelin has been observed. The purpose of this study is to investigate if patients with protein C deficiency also have elevated levels of ghrelin, and if so, how this affects the patients.
30 patients with protein C deficiency and 30 healthy BMI and gender matched controls are recruited. Bloodsamples are taken in order to measure ghrelin and GH levels and other metabolic parameters. The patients and controls are also asked to answer a questionaire regarding appetite.
If patients with protein C deficiency have higher levels of ghrelin than the general population, this will lead to new studies that will perhaps help us understand the importance of ghrelin in humans.
- Conditions
- Protein C Deficiency
- Being tested
- Protein C deficiency
- Keywords
- ghrelin, growth hormone, protein C deficiency, appetite
- Medical subject headings
- Protein C Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein C deficiencyGenetic
The effect of protein C deficiency on ghrelin levels are investigated.
| Study group | Role | What they receive |
|---|---|---|
| Patients with protein C deficiency | Patient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made. Receives: Genetic: Protein C deficiency | |
| Healthy controls | Patient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
acyl ghrelin and des acyl ghrelin measured in mg/dl
Measured: 6 month
Secondary outcomes (1)
Growth hormone measured in pmol/L
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study startJan 2020 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein C DeficiencyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180657
- Sponsor's protocol ID
- 69965
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Ghrelin Levels in Patients With Protein C Deficiency
- ClinicalTrials.gov ID
- NCT04180657
- Acronym / sponsor ID
- 69965
- Conditions
- Protein C Deficiency
- Keywords
- ghrelin, growth hormone, protein C deficiency, appetite
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In rodents with protein C deficiency elevated levels of ghrelin has been observed. The purpose of this study is to investigate if patients with protein C deficiency also have elevated levels of ghrelin, and if so, how this affects the patients.
30 patients with protein C deficiency and 30 healthy BMI and gender matched controls are recruited. Bloodsamples are taken in order to measure ghrelin and GH levels and other metabolic parameters. The patients and controls are also asked to answer a questionaire regarding appetite.
If patients with protein C deficiency have higher levels of ghrelin than the general population, this will lead to new studies that will perhaps help us understand the importance of ghrelin in humans.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with protein C deficiency | – | Genetic: Protein C deficiencyPatient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made. |
| Healthy controls | – | –Patient and control group are compared regarding ghrelin, growth hormone levels and appetite, and no other intervention is made. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with protein C deficiency and gender and BMI matched controls.
Key inclusion criteria (4 listed)
- protein C deficiency or healthy subjects
- age 18-70
- BMI 18-35
- written statement to join the study
Key exclusion criteria (4 listed)
- chronic illness, apart from protein C deficiency and lifestyle diseases
- everyday medication apart from statins, oral diabetes medication and antihypertensive drugs.
- blood donation within three months prior to the investigation.
- Alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein C deficiencyThe effect of protein C deficiency on ghrelin levels are investigated. | Genetic | Patients with protein C deficiency |
Primary outcome
acyl ghrelin and des acyl ghrelin measured in mg/dl
Time frame: 6 month
1 secondary outcome
Growth hormone measured in pmol/L
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakel F Johansen, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Protein C Deficiency, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sascha S Horup, MD (+45 27149089, SASHOR@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acyl ghrelin and des acyl ghrelin measured in mg/dl (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.